Laboratory Developed Tests

Inside Health Policy: Clinical Lab Group Outlines Legal Arguments Against FDA’s LDT Oversight

The American Clinical Laboratory Association, the group heading up efforts to quash FDA’s planned oversight of laboratory developed tests (LDTs), released a white paper Wednesday (Jan. 7) blasting FDA’s proposed regulatory framework as “a dramatic overreach” without “any statutory basis.” The paper, authored by ACLA’s recently tapped counsel, Harvard University law professor Laurence Tribe and former Solicitor General Paul Clement, now a partner with Bancroft PLLC, lays out potential legal arguments against the framework and was released a day before FDA’s Thursday (Jan. 8) public meeting on the issue.

At issue is FDA’s plan, laid out in draft guidance, to apply the existing device classification system to LTDs over a nine-year implementation period.

The ACLA paper alleges FDA lacks statutory standing for its proposed regulatory framework because LDTs do not fit under the definition of a “device.” If FDA moves forward, the authors say, the agency would not be not equipped to bear the regulatory burden and would interfere with the practice of medicine. The paper also takes issue with FDA’s use of a guidance document to advance new regulatory policy, saying this strategy circumvents requirements of rulemaking, including the requirement for an economic impact analysis.

Statutory overreach. The paper argues that LDTs do not fit under the definition of a “device” and therefore the Food, Drug and Cosmetic Act does not provide authority to the agency to regulate these tests.

“FDA ignores the fact that the statute does not classify based on functionality, but on whether something is a physical article that a manufacturer commercially distributes in interstate commerce,” states the paper.

The paper also criticizes FDA’s premise that doctors are relying on laboratory tests that are “unapproved” devices, saying it underscores the extreme implication of the agency’s interpretation of FDCA: that the entire medical profession has, unbeknownst to doctors, been involved in the widespread illegal distribution of unapproved medical devices since 1976. “Under FDA’s theory, every doctor who sends a specimen for analysis via a laboratory-developed testing service is really soliciting an unlawful medical device,” the authors state.

Innovation implications. ACLA’s paper alleges that FDA oversight of such tests would “sharply curtail” the number of tests available to doctors and their patients, pointing out that a large number of critical diagnostic tests are available only as in-house laboratory tests. FDA oversight would “stunt and stifle” innovation and competition in the diagnostic testing field, the authors state.

Regulatory burden. “As a practical matter, moreover, FDA is manifestly not equipped to bear the massive regulatory burden it claims that Congress intended it to shoulder,” argues the group. “FDA has projected that it would take near a decade for it to phase in its asserted regulatory authority over laboratory-developed testing services. That it would take that many years to handle the full scope of the administrative responsibilities it asserts is yet another indication that Congress never intended for FDA’s preexisting (and ill-suited) regulations over drugs and devices in interstate commerce to sweep in laboratory-developed testing services.”

Inadequate public comment. Further, the attorneys say the agency failed to undertake the notice-and-comment procedures that would be required to create the proposed framework, and that the use of a guidance document was an improper way to move forward on the new policy. They also note that the guidance document does not consider the cost and economic impact of the proposed requirements, which is required when the agency goes through the rulemaking process.

No economic impact analysis. “The absence of an economic impact analysis is a particularly glaring omission given the sweeping practical effects of FDA’s radical change in policy,” the paper states. “As noted, FDA’s assertion of jurisdiction will significantly burden clinical laboratories, superimposing a duplicative bureaucratic regime on a vibrant and constantly evolving laboratory testing industry that is already closely regulated under CLIA, and that FDA has no prior experience in regulating.”

But the Advanced Medical Technology Association, which supports FDA’s regulatory plan, said the lab group’s legal arguments are an “attempt to obscure the fact tests are a regulated tool that doctors us in the care of patients.” AdvaMed Diagnostics Executive Director Andrew Fish said the practice of medicine exemption does not appropriately extend to the development of tests. “The test itself is a medical device,” said Fish.

A former senior FDA reviewer also said he feels that the matter of whether FDA has jurisdiction over LDTs is a reasonably settled issue and stakeholders should focus on working with the agency.

FDA is interested in listening to stakeholders’ views on how the agency can best regulate these tests, said Lakshman Ramamurthy, director of FDA and regulatory policy at Avalere Health, adding that the agency should find a balance between safety and innovation. He also described FDA’s draft guidance as just laying the “groundwork” for the agency’s framework. — Erin Durkin (edurkin@iwpnews.com)

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